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LEADERS FREE II: BioFreedom™ Pivotal Study

NCT02843633 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1203

Last updated 2021-02-03

No results posted yet for this study

Summary

This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study (NCT01623180) in high bleeding risk patients.

Conditions

  • Acute Coronary Syndrome
  • High Bleeding Risk

Interventions

DEVICE

BioFreedom™ Drug Coated Coronary Stent System

a non-surgical procedure that uses a catheter to place a stent to open up coronary arteries that have been narrowed by atherosclerosis

DRUG

Antiplatelet Drug

Dual antiplatelet therapy for one month followed by single antiplatelet therapy indefinitely. Aspirin and clopidogrel (or other P2Y12 inhibitor) will be used and dosing is according to standard institutional practice

Sponsors & Collaborators

  • Biosensors Europe SA

    lead INDUSTRY

Principal Investigators

  • Martin Leon · Cardiovascular Research Foundation, New York

  • Mitchell Krucoff · Duke University

  • Philip Urban · Hôpital de la Tour

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-14
Primary Completion
2018-10-11
Completion
2021-03-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • Denmark
  • France
  • Germany
  • Italy
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02843633 on ClinicalTrials.gov